Condition category
Digestive System
Date applied
19/11/2007
Date assigned
04/03/2008
Last edited
05/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Linas Venclauskas

ORCID ID

Contact details

Eiveniu str. 2
Kaunas
LT50009
Lithuania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

73/2007

Study information

Scientific title

Acronym

Study hypothesis

1. Open mesh repair hernia surgery is better than suture repair hernia surgery of incision hernia treatment
2. The recurrence rate using suture hernia repair technique is much higher than mesh repair technique
3. The recovering time to the normal physical activity after surgery is faster, quality of life is better using mesh repair with sublay technique than mesh repair with onlay technique or suture repair technique of the incision hernia treatment

Ethics approval

Ethics approval received from Kaunas Biomedical Research Ethics Committee on the 5th June 2007 (ref: BE-2-41).

Study design

Blinded, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Hernia

Intervention

Three groups:
1. Keel technique
2. Onlay technique
3. Sublay technique

The follow up period is 2 weeks, 1, 3, 6 and 12 months after surgery. Surgery, blood gas analysis and intra-abdominal pressure investigation before and after operation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Recurrence rate, measured at 2 weeks, 1, 3, 6 and 12 months after surgery
2. Quality of life, measured using the 36-item Short Form health survey version 2 (SF-36 v2)at 2 weeks, 1, 3, 6 and 12 months after surgery

Secondary outcome measures

1. Postoperative complications, measured at 2 weeks, 1, 3, 6 and 12 months after surgery
2. Change of the blood gas and intra-abdominal pressure, measured before and after surgery
3. Recovering time to the normal physical activity after surgery, measured at 2 weeks, 1, 3, 6 and 12 months after surgery

Overall trial start date

01/07/2007

Overall trial end date

01/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All 18 - 80 years old patients with incision hernia, who will be operated and agree to participate in this clinical trial.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 patients in each group, 150 patients in all

Participant exclusion criteria

1. Patients older than 80 years
2. Incarcerated incision hernia
3. Mental patients with incision hernia
4. Pregnant women with incision hernia
5. Patients with incision hernia do not agree to participate in this clinical trial

Recruitment start date

01/07/2007

Recruitment end date

01/07/2008

Locations

Countries of recruitment

Lithuania

Trial participating centre

Eiveniu str. 2
Kaunas
LT50009
Lithuania

Sponsor information

Organisation

Kaunas Medical University Hospital (Lithuania) - Department of Surgery

Sponsor details

Eiveniu str. 2
Kaunas
LT50009
Lithuania

Sponsor type

Hospital/treatment centre

Website

http://www.kmu.lt/

Funders

Funder type

Hospital/treatment centre

Funder name

Kaunas Medical University Hospital (Lithuania) - Department of Surgery

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes